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DRUG CLASS AND MECHANISM: Tretinoin is a derivative of vitamin A. It is used on the skin (topically) in the treatment of mild to moderate acne and on skin that has been damaged by excessive exposure to the sun. Tretinoin irritates the skin and causes the cells of the skin to grow (divide) and die more rapidly, increasing the turnover of cells. The number of layers of cells in the skin actually is reduced. In patients with acne, new cells replace the cells of existing pimples, and the rapid turnover of cells prevents new pimples from forming. By a similar mechanism, tretinoin can reduce some wrinkles, areas of darkened skin (hyperpigmentation), and rough areas of skin, all of which occur in sun-damaged skin. In patients with sun-damaged skin, improvements in the skin usually are seen within the first 3 to 4 weeks of treatment. Brown spots begin to fade after six to eight weeks. Wrinkles decrease or disappear after three to six months. Following application to the skin, a minimal amount of drug is absorbed into the body. The FDA approved topical tretinoin in 1971.

Renova .05% is a skin cream that reduces fine facial wrinkles, brown spots, and surface roughness associated with chronic sun exposure and the natural aging process when used in addition to a comprehensive skin care and sun avoidance program. Renova is an additional therapy for persons who do not achieve satisfactory results using a sunscreen, protective clothing and moisturizers alone. It does not eliminate wrinkles, repair sun damaged skin or reverse either the aging process or photoaging.

Renova contains the active ingredient tretinoin, a vitamin A metabolite that occurs naturally in the body.

While over the counter alpha hydroxy acids are thought to work primarily on the surface of the skin to remove dead skin cells and moisturize, Renova is believed to work on all layers of the skin, including the epidermis where pigmentary changes occur and even the deeper portions of the skin where fine wrinkling begins.

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Clinical Results

More than 300 subjects between the ages of 30 and 50 participated in the clinical studies of Renova, which were conducted during a 48-week period at eight research centers nationwide. Subjects received treatment for up to 48 weeks with Renova or a placebo, in conjunction with a comprehensive skin care and sun avoidance program.

Almost all Renova users experienced side effects before seeing visible improvement. These side effects are temporary, usually mild to moderate in severity, and may include some redness, dryness, itching, peeling, or a slight burning or tingling sensation. In clinical studies, these skin reactions were temporary and usually disappeared within a few weeks after therapy began. In most patients, the dryness, peeling, and redness recurred after an initial (24 week) decline. During these studies, only 4% of patients discontinued Renova due to adverse reactions.

However, Renova is considered to be a dermal irritant, and the results of continued irritation of the skin for greater than 48 weeks are not known. There is evidence of atypical changes in malanocytes and keratinocytes, and or increased dermal elastosis in some patients treated with Renova for longer than 48 weeks. The significance of these findings is unknown. Safety and effectiveness of Renova in individuals with moderately or heavily pigmented skin have not been established, as well.